Why Area Is Important

A catastrophic biological event, such as a terrorist attack with a weapon of mass destruction or a naturally occurring pandemic, could cause mass casualties, weaken the economy, damage public morale, and threaten national security. Biodefense includes measures to prevent, detect, respond to, and recover from harm or damage caused by microorganisms or biological toxins to humans, animals, or the food supply. In January 2010, the bipartisan Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism (now known as the WMD Center), which was established by the Implementing Recommendations of the 9/11 Commission Act (Pub. L. No. 110-53, § 1851), gave the nation a failing grade in its efforts to enhance capabilities for rapid response to prevent biological attacks from inflicting mass casualties.

What GAO Found

According to the head of the WMD Center, there are more than two dozen presidentially appointed individuals with some responsibility for biodefense. In addition, numerous federal agencies, encompassing much of the federal government, have some mission responsibilities for supporting biodefense activities. However, there is no individual or entity with responsibility, authority, and accountability for overseeing the entire biodefense enterprise.

According to Homeland Security Presidential Directive 10, published in April 2004, successful implementation of the nation's biodefense enterprise requires optimizing critical cross-cutting functions such as information management and communications, research and development, and acquisition. In 2004, GAO reported that interagency and intergovernmental activities can benefit from the leadership of a single entity with sufficient time, responsibility, authority, and resources needed to provide assurance that the federal programs are well coordinated, and that gaps and duplication in capabilities are avoided. GAO also reported in 2001 that complex interagency and intergovernmental efforts can benefit from developing a national strategy.

Biodefense is organized into four pillarsthreat awareness, prevention and protection, surveillance and detection, and response and recoveryand multiple federal agencies have some biodefense responsibilities within them, as shown in the figure below. Each of these pillars comprise numerous activitiessuch as controlling access to dangerous biological agents used in researchthat generally require coordination across federal departments as well as with state, local, and international governments, and the private sector. Deterrence of bioterrorism rests upon the ability of the nation to mitigate the effects of an attack.

According to the WMD Center's January 2010 report, Prevention of WMD Proliferation and Terrorism Report Card, there is no national plan to coordinate federal, state, and local efforts following a bioterror attack, and the United States lacks the technical and operational capabilities required for an adequate response. The report goes on to say that these technical and operational capabilities are each links in a chain, critical to the strength of the attack response, and that weakness in any capability leads to a diminished response, and diminished effectiveness in deterring an attack.

Pillars of Biodefense and Examples of Associated Federal Departments

GAO's past work has highlighted fragmentation in the surveillance and detection pillar, which indicates the need for strategic oversight mechanismssuch as a national strategy and a focal pointacross the entire biodefense enterprise. In June 2010, GAO reported that an activity in the surveillance and detection pillar known as biosurveillance is fragmented and that the decision makers responsible for developing a national biosurveillance capability are spread across multiple agencies and departments, as it is with the rest of the biodefense enterprise. Yet, strategic oversight mechanisms, such as a focal point or national strategy, had not been established to coordinate and lead efforts across the multiple federal departments with biosurveillance responsibilities. GAO recommended that the Homeland Security Council, which was established to serve as a mechanism for ensuring coordination of federal homeland security-related activities and development of homeland security policies, should direct the National Security Staff to establish a focal point and charge this focal point with the responsibility for developing a national biosurveillance strategy. The National Security Staff did not comment on these recommendations.

While some high-level biodefense strategies have been developed, there is no broad, integrated national strategy that encompasses all stakeholders with biodefense responsibilities that can be used to guide the systematic identification of risk, assessment of resources needed to address those risks, and the prioritization and allocation of investment across the entire biodefense enterprise. Further, neither the Office of Management and Budget nor the federal agencies account for biodefense spending across the entire federal government. As a result, the federal government does not know how much is being spent on this critical national security priority. However, a private sector analysis of the fiscal year 2011 federal budget for civilian biodefense estimates that the U.S. biodefense effort will total $6.48 billion across 8 of the more than 12 federal agencies with biodefense responsibilities. GAO's work noted that having a strategy in place to guide development of a national biosurveillance capability could potentially help agencies address challenges that are complex, inherent to building capabilities that cross mission areas and agencies, and not easily resolvedchallenges that are also present in the larger biodefense enterprise. A national strategy could define the scope of the problems to be addressed, and in turn could lead to specific objectives and activities for tackling those problems, better allocation and management of resources, clarification of roles and responsibilities, and, finally, to integration of a biodefense strategy with other related preparedness and response strategies. In addition, because responsibilities and resources are dispersed across a number of federal agencies, the nation's biodefense enterprise could benefit from designated leadershipa focal pointthat provides leadership for the interagency community.

Actions Needed

Because none of the departments has authority over the entire biodefense enterprise, the Homeland Security Council should consider establishing a focal point to coordinate federal biodefense activities, including biosurveillance, consistent with GAO's previous recommendation for the Council to establish a focal point for biosurveillance. The overarching biodefense enterprise would benefit from strategic oversight mechanisms, including a focal point such as a national biodefense coordinator and a national strategy, to ensure efficient, effective, and accountable results. Reduced fragmentation in the biodefense enterprise could enhance assurance that the nation is prepared to prevent, detect, and respond to biological attacks with potentially devastating consequences in terms of loss of life, economic damage, and decreased national security.

Framework for Analysis

The information contained in this analysis is based on the related GAO products listed under the "Related GAO Products" tab. GAO also has work under way on threat and risk assessments and countermeasure development, which focuses on issues of integration and coordination across multiple agencies and expects to report on its results in spring 2011.

Area Contact

For additional information about this area, contact William O. Jenkins at (202) 512-8777 or jenkinswo@gao.gov.